Containers for closed system single-use bioreactors and culture vessels

Abstract

A multiport container system for use in cell culture processes in the field of regenerative medicine is disclosed. Specifically, the container system can have a port that connects to a fill tubing for media and reagent addition, and additional ports for tubing and connectors which are compatible to various types of cell therapy bioreactors, single use bags, as well as different sampling and cell culture systems. The multiport container system can be used for cell production processes where a single bag could be used to fill, transport, and store media or reagents, as well as to seed and feed cells into different types of culture platform. The disclosed multiport container system can be used for the streamlining of process work flow which enable rapid process development and process transfer into cell product manufacturing.

1 . A multiport container, comprising
 a) a bag having an interior volume of from 1 L to 500 L;   b) a fill tubing having a proximal end fluidly connected to the interior volume of the bag and a distal end extending away from the bag;   c) at least one dispense tubing having a proximal end fluidly connected to the interior volume of the bag and a distal end extending away from the bag;   d) a first intermediate connector fluidly connected to the distal end of the at least one dispense tubing, and a first connection tubing having a proximal end fluidly connected to the first intermediate connector and a distal end extending away from the bag;   e) optionally a second intermediate connector fluidly connected to the distal end of the first connection tubing and a second connection tubing having a proximal end fluidly connected to the second intermediate connector and a distal end extending away from the bag; and   f) a terminal connector fluidly connected to the distal end of the first or second connection tubing;   wherein the multiport container comprises at least six distinct configurations, sizes, or a combination thereof, of dispense tubing, connection tubing, intermediate connectors, and terminal connectors.   
     
     
         2 . The container of  claim 1 , wherein the intermediate connector comprises a splitter, wherein at least two first connection tubings are fluidly connected to the first intermediate connector in parallel. 
     
     
         3 . The container of  claim 1 , comprising two dispense tubings extending away from the bag in parallel, each dispense tubing fluidly connected to the interior volume of the bag. 
     
     
         4 . The container of  claim 1 , further comprising an in-line filter fluidly connected to the distal end of the fill tubing. 
     
     
         5 . The container of  claim 1 , wherein the multiport container comprises at least six distinct configurations, sizes, or a combination thereof, of intermediate and terminal connectors. 
     
     
         6 . The container of  claim 1 , wherein each of the fill tubing, dispense tubing, and connection tubing have a length of from 6 inches to 50 inches. 
     
     
         7 . The container of  claim 1 , wherein each of the fill tubing, dispense tubing, and connection tubing have an inner diameter from 0.1 inch to 1 inch. 
     
     
         8 . The container of  claim 1 , wherein each of the fill tubing, dispense tubing, and connection tubing have a wall thickness from 0.03 inches to 0.25 inches. 
     
     
         9 . The container of  claim 1 , configured for containment of media and reagents at temperature between 4-37° C. prior to use 
     
     
         10 . The container of  claim 1 , wherein the dispense tubing, extension tubing, or a combination thereof is configured for welding onto single use cell culture systems such as cell stacks/factories, bioreactors 
     
     
         11 . The container of  claim 1 , wherein the intermediate connector, terminal connector, or a combination thereof, are configured for connection to a syringe or bag for process additives. 
     
     
         12 . The container of  claim 1 , wherein the intermediate connector, terminal connector, or a combination thereof, are configured for connection to a cell or microcarrier inoculation system. 
     
     
         13 . The container of  claim 1 , wherein the intermediate connector, terminal connector, or a combination thereof, are configured for dispensing of a solution from the interior volume of the bag into single use cell culture systems such as cell stacks/factories, and bioreactors. 
     
     
         14 . The container of  claim 1 , wherein the intermediate connector, terminal connector, or a combination thereof, are configured for solution sampling and waste or spent media collection. 
     
     
         15 . The container of  claim 1 , comprising a bar code, RFID, NFC tag, or a combination thereof for identification. 
     
     
         16 . The container of  claim 1 , wherein the multiport container comprises at least four distinct configurations, sizes, or a combination thereof, of intermediate connectors, terminal connectors, or any combination thereof. 
     
     
         17 . The container of  claim 1 , wherein the multiport container comprises at least three distinct configurations, sizes, or a combination thereof, of dispense tubing and connection tubing. 
     
     
         18 . The container of  claim 1 , wherein at least one intermediate connector, terminal connector, or a combination thereof is selected from the group consisting of MPC, CPC, Luer lock, AseptiQuick®, ReadyMate®, PureFit®, Opta-SFT®, KleenPak®, Lynx S2S®. 
     
     
         19 . A cell expansion kit comprising
 a) the container of  claim 1  filled with cell culture media;   b) a bag of frozen or non-frozen cell culture supplement for adding additional nutritional and growth supplements to the media;   c) optionally, a bag of frozen cells for seeding into the media bag;   d) optionally, a bag of microcarriers;   e) optionally, a bag of harvest enzyme; and   f) optionally, a cell culture bioreactor or culture vessel.   
     
     
         20 . The cell expansion kit of  claim 19 , configured for generating from 50 million to 100 billion therapeutic or non-therapeutic cells per lot.